FDA.reportPublic FDA data

PC Electrometer Reference Class Dual-Channel Electrometer (BNC)

Primary DI
B01610140000Z0
Brand
PC Electrometer Reference Class Dual-Channel Electrometer (BNC)
Company
SUN NUCLEAR CORP.
Model
10140000Z
Catalog number
10140000Z
Device description
Radiation therapy QA device.
Published
2017-01-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092019000MODEL 1014 PC ELECTROMETERSun Nuclear Corp.2009-09-15IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B01610140000Z0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiation electrometerA stand-alone external measuring device with a detection circuit that can be used with different ion chamber probes for conducting dosimetry measurements in high radiation fields. An electrometer typically includes output read out capabilities in charge, current, time, dose and dose rate.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure18.7 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-30 Degrees Celsius50 Degrees Celsius
Special Storage Condition, Specify00Before storage, install caps on both detector inputs. The input connector interior has high impedance; the caps protect the inputs from contamination which could cause increased leakage current.
Special Storage Condition, Specify00Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Storage Environment Atmospheric Pressure57.2 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
122240021
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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